A major step forward in its flagship product deployment in solid tumors.

ERYTECH Pharma has just completed the enrollment of patients in a Phase I clinical trial with its flagship product for pancreatic cancer, Graspa®. This product contains the enzyme L-asparaginase encapsulated in red blood cells, using technology owned by ERYTECH Pharma. The first results in this study demonstrated that Graspa® was active, with a safety profile that was satisfactory for patients in last-line therapy. On the back of this success, ERYTECH is expecting to forge ahead with the clinical development of Graspa® for the treatment of pancreatic cancer in “responder” patients.

Dr Yann Godfrin (ERYTECH Pharma’s co-founder, Vice President and Chief Scientific Officer) commented “We are delighted with these results in pancreatic cancer. Graspa® showed good safety and tolerability in these particularly fragile patients, whereas other clinical studies have shown significant toxicity with forms of asparaginase. We had obtained the same results in leukemia; it is the first time in a solid tumor”.

Pancreatic cancer remains a significant medical challenge, with over 140,000 new cases reported every year in Europe and the USA. It is the ninth-ranked cause of cancer-related death in Europe. Published academic studies and ERYTECH’s own research on mice and on patient samples have shown that a subgroup of tumors is sensitive to the action of L-asparaginase. In order to select responders, ERYTECH is working with private-sector and academic partners with a view to fine-tuning a predictive test for the efficacy of encapsulated asparaginase. Of note is a research agreement signed with the MD Anderson Cancer Center in the US, which has identified a biomarker for the prediction of L-asparaginase on solid tumors.

Professor Thierry André (the Hepatogastroenterology Department at Pitié-Salpêtrière Medical Centre and investigator of the study) emphasized that “asparagine depletion appears to be an attractive approach to treating this cancer. It would be especially valuable if, in future clinical studies, we could select patients likely to show a treatment response to this depletion”.

Pierre-Olivier Goineau, co-founder and Chairman concluded by saying that “with Graspa®’s efficacy and tolerance profile, we are expecting to widen its scope for appropriate use - particularly in solid tumors.The overall potential market for Graspa® could well amount up to several million Euros in the future.”

Graspa® has been granted orphan drug designation by the European Medicines Agency for the treatment of pancreatic cancer. It has also received this status in Europe and in the USA for the treatment of acute lymphoblastic leukemia. ERYTECH Pharma’s use of encapsulation technology opens up new cancer treatment possibilities, in which enhanced efficacy and reduced toxicity are key elements in an improved prognosis and quality of life for patients.

About Graspa®

Graspa® is a new enzyme formulation of L-asparaginase, with a safer and broader range of clinical uses than existing forms due to the enzyme’s entrapment and protection inside homologous red blood cells. The added value of Graspa® (by encapsulating L-asparaginase in red blood cells) relates to its ability to overcome existing limitations associated with conventional L-asparaginase via longer efficacy, better compliance, reduced doses and a better safety profile.

About ERYTECH Pharma

ERYTECH Pharma (based in Lyons and Philadelphia) is a specialty pharma company developing innovative therapeutic solutions based on its proprietary technology and expertise in the physiological properties of erythrocytes. The company addresses serious pathologies, orphan indications or particular patient subpopulations, particularly in the fields of hematology, cancer and metabolic diseases. In less than six years, it has built a strong pipeline with very ambitious programs and a powerful, proprietary R&D platform with significant potential for new therapeutics and applications.